BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTOBASE RETRACTOR RACK

    MDR report key: 1971344 · Received January 7, 2011

    Report

    Report Number
    2135394-2011-00003
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION SHOWED THE RETRACTOR HANDLE WAS BROKEN AND RETURNED IN TWO PIECES. FURTHER INSPECTION SHOWED A BEND IN THE METAL POST. PERFORMANCE TESTING WAS NOT PERFORMED, AS THE UNIT WAS CONSIDERED NON-FUNCTIONAL. CONCLUSION: THE CAUSE FOR THIS EVENT CANNOT BE DETERMINED AT THIS TIME. FURTHER INVESTIGATION IS PENDING. UPON FURTHER INFO, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THE HANDLE OF THE OCTOBASE WAS BEND AND FELL APART WHILE IN THE CHEST OF THE PT. ALL PARTS WERE SUCCESSFULLY RETRIEVED WITH NO ADVERSE PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTOBASE RETRACTOR RACK DWS MEDTRONIC PERFUSION SYSTEMS 28701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R